Cleared Traditional

K872548 - FITNESS RECUMBENT ERGOMETER

K872548 is an FDA 510(k) clearance for FITNESS RECUMBENT ERGOMETER, manufactured by Invacare Corp.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K872548 · Invacare Corp. · Cardiovascular device
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Dec 1987
Decision
169d
Days
Class 2
Risk

K872548 is an FDA 510(k) clearance for the FITNESS RECUMBENT ERGOMETER, MODEL FT1400. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Invacare Corp. (Elyria, US). The FDA issued a Cleared decision on December 15, 1987 after a review of 169 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Invacare Corp. devices

FDA 510(k) Submission Details - K872548

510(k) Number K872548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1987
Decision Date December 15, 1987
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DPS Electrocardiograph

All 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K872548.
HORIZON 2000/S 266-XXX-XXX
K880595 · Mennen Medical, Inc. · May 1988
FUKUDA MODEL DS-503 DYNASCOPE PATIENT MONITOR
K875057 · Fukuda Denshi USA, Inc. · Mar 1988
MODEL 980-CARDIOSCOPE AT-3 ELECTROCARDIOGRAPH
K872658 · Del Mar Avionics · Jan 1988
MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR
K873584 · Quinton, Inc. · Oct 1987
MODEL 2240 SLAVE SCOPE
K873346 · Marquette Electronics, Inc. · Oct 1987
ACUSON PHYSIOLOGICAL CONTROL MODULE
K871239 · Acuson Computed Sonography · Jun 1987